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Illumina Enters Second Wave Of Growth As Genomics Demand Swells

Illumina is capitalizing on the inexorable rise of genomics, as governments around the world step up their focus on precision medicine and deliver higher quality, yet more cost-effective, health care to the population. Paula Dowdy, who joined the firm as head of its EMEA commercial operations a year ago, believes that Europe will lead the charge in making genomics a core component of health care, and the growth story of the company – and the genomics sector as a whole – is far from over. She speaks to Medtech Insight about the parallels between the tech industry, where she had garnered over 20 years' commercial experience, and the genomics sector and gives her perspectives on Illumina's strategies for sustaining the growth trajectory of its EMEA business.

Business Strategies Leadership In Vitro Diagnostics

Artificial Intelligence Brings Wave Of Future Health Care Innovation – Embrace it or be Left Behind

Artificial intelligence and machine-learning will be the biggest disrupters in the health care industry, forcing a major shift in how companies innovate and operate, offering physicians unprecedented tools to diagnose and treat patients to improve outcomes and connecting patients like never before through consumer-driven devices. This feature takes a close look at how smaller companies and giants like Abbott, as well as national health care systems, are leveraging the power of AI to expedite innovation and product development in diabetes and other diseases. It highlights some of the latest studies that show how AI is being harnessed to improve imaging analytics, predict hard-to-find risk factors for heart disease and detect cancer, and discusses the critical role tech giants such as IBM, Google and Amazon continue to play in this space.

Digital Health Personalized Medicine Market Intelligence

Cyber Insurance Offerings Growing In Response To New Threats

Insurers are reformulating their policies for device firms and others to meet the new threat of cyber attacks in the health-care arena, according to experts from the law firm Covington & Burling.

Safety Risk Management Digital Health

Device Week – US Policy Roundup, July 28, 2017

In this week's podcast, Medtech Insight journalists discuss what was a busy week in Washington, DC: The health-care failure on Capitol Hill, and what it means for medtech; FDA's new plan for digital health; and one case to watch during the US Supreme Court's next term.

United States Policy Regulation

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Policy & Regulation Explore this Topic

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Software At The Speed Of Trust: US FDA Launches Pilot To Expedite Digital Health Products

Nine companies are asked to volunteer for a pilot program that could lead to a new pathway for sponsors of digital health products. Under the plan, the agency would allow firms to market a product with fewer if any pre-market review requirements based on trust developed in the company's software design and testing. If the project works out, FDA digital health leader Bakul Patel tells Medtech Insight, the agency hopes it will attract more non-traditional medical device firms that specialize in software development.

Digital Health Regulation FDA

UK’s NICE Updates Policy For Preventing Bias In Advisors

Health technology assessment body NICE wants feedback on its revised policy on declaring and managing any conflicts of interest of its advisory committees.

United Kingdom Health Technology Assessment Policy & Regulation

Podcast: Game Changer For Digital Health? A Talk With FDA's Bakul Patel

In an exclusive podcast interview with Medtech Insight, US FDA's Bakul Patel talks about the agency's new Digital Health Software Precertification Program and the pilot project launched to help figure out how to make it work.

Digital Health Regulation

Tighter Australian Rules Spell More Work For Surgical Mesh And Other Implant Makers

The Therapeutic Goods Administration wants feedback on planned changes that would align Australian medical device rules with the new medtech rules in Europe.

Australia Regulation

Health-Care Bill Failure Triggers Renewed Search For Device Tax Repeal Option

The early morning failure of a "skinny repeal" health care bill on July 28 caused by the defection of Republican Sens. John McCain, Lisa Murkowski and Susan Collins was also a setback for device lobbyists, as the bill contained an extended delay of the device tax until Dec. 31, 2020. But with the Obamacare repeal effort over for now, there may be quicker action on another top industry priority –passage of FDA user-fee reauthorization.

Policy Legislation

Snapshot: US Pediatric Device Approvals Stay Steady, Despite Overall FDA Surge

The 18% of FY 2015 PMA and HDE device approvals that included pediatric indications was the lowest proportion since FY 2009, even while, overall, 2015 was a record-setting year for novel device approvals.

Regulation Pediatrics

Capitol Hill Update: Congress Gets Reprieve On User Fee Passage, While AdvaMed Weighs Device Tax Options

Commissioner Gottlieb says the agency won't issue layoff notices "unless and until Sept. 30 passes without reauthorization" of US FDA user fee programs. Meanwhile, could the user fee bill be a vehicle for device tax repeal?

Policy Legislation

German Electromed Industry View Of Brexit: We Can Cope

The German electromedical industry has surveyed it members on the potentially negative impacts of Brexit on business continuity. Findings suggest that the effects will be manageable.

Germany Brexit

Quality Control & Compliance Explore this Topic

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US FDA Maturity Model Pilot Program Gets October Meeting Date

The agency wants to hear public feedback on its plan to employ a standardized model to measure a company's manufacturing "maturity" via third-party assessments to support regulatory and compliance decisions.

Quality Control Compliance

Compliance Corner: 6 Tips From US FDA To Ensure Robust Software Validation

Device manufacturers can avoid headaches during agency inspections by following this advice from two FDA investigators.

Quality Control Compliance

Aerospace Heat Treating Standard Recognized By US FDA, Giving Nudge To MedAccred Supplier-Control Program

The agency's Center for Devices and Radiological Health has formally recognized pyrometry standard AMS 2750 for heat treating. Originally drafted by SAE International in 1980 for the aerospace industry, the standard is the foundation of heat treating audit criteria for the burgeoning medical device supply-chain oversight program MedAccred.

Quality Control Medical Device

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Relentless Rise Of Transcatheter Tech: Heart Valve Repair Turns Back On Open Surgery

The global market for products treating heart valve disease is expected to exceed $8bn by 2021, driven largely by the rising number of elderly patients with cardiovascular disease, obesity and growing prevalence of diabetes. This, in turn, is fueling significant innovation in minimally invasive techniques, particularly in the leading area of transcatheter aortic valve replacement (TAVR), but also in transcatheter mitral valve repair (TMVrep) systems, both of which offer patients quicker recovery times, less discomfort and greater safety compared to traditional surgical heart valve repair and replacement. This feature looks more closely at the competitive landscape and dynamics of these two fast-growing market segments, as well as gives insight into what the users – the physicians – think of these technologies.

Cardiovascular Surgical Procedures Market Intelligence

Latest From Commercial

Angle Reels In Positive Clinical Results In Ovarian Cancer Study

Liquid biopsy company Angle plc, has reported positive results for its first large-scale study in Europe and the US using its Parsortix system to detect ovarian cancer. The study evaluated 400 patients for the detection of ovarian cancer in women with a high-risk pelvic mass.

Clinical Trials Cancer

US Supreme Court Case Could End Patent Office Reexamination Procedure

The court has agreed to take an oil-industry case challenging patent office inter partes review procedures on the grounds they violate a constitutional right to trial by jury. IPRs have become an increasingly common approach in medtech and elsewhere for challenging patents outside of court, but not without controversy.

Intellectual Property Commercial

Apollo Endosurgery Inflates Coffers With $36m

Anti-obesity device company Apollo Endosurgery has closed a $36m share offering.

Financing Deals

Estrampes Appointed To Helm Of GE Healthcare EU

GE Healthcare has appointed Catherine Estrampes as CEO of its European operations, replacing Jean-Michel Malbrancq who is leaving to pursue opportunities outside of GE after 35 years with the company.

Companies Appointments

Apollo Endosurgery Seeks To Raise $31m In Share Sale

Anti-obesity device company Apollo Endosurgery is looking to net around $31m through a sale of 5.7 million shares. The Austin, Texas-based company has seen slow sales in the last couple of years and is planning to use the funds to boost adoption of its endo-bariatric products, which includes the Orbera intragastric balloon and the Lap-Band gastric band which it inherited through acquiring Allergan’s obesity intervention division in 2013.

Financing Deals

Alere Off-Loads Blood Gas Business To Siemens

Alere is selling its Epocal point-of-care blood diagnostics subsidiary to Siemens Healthineers to comply with US antitrust requirements in advance of its pending acquisition by Abbott. Siemens plans to integrate Epocal's epoc blood analysis system with its digital platforms and its existing point-of-care diagnostics.

Commercial Deals

Clinical R&D Explore this Topic

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Starts And Stops: Abbott And Boston Scientific Lead Big List Of Trial Announcements

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions, and suspensions each month. This month's edition, covering the period between mid-June and mid-July, represents a wide variety of devices and companies, including many of the biggest medtech players.

Starts & Stops Clinical Trials Innovation

Latest From Research & Development

Humabs Biomed Zika Assay Pinpoints Virus From Other Flavivirus Infections

A novel antibody-based Zika virus assay developed by Humabs Biomed, the NS1 Blockade-of-Binding (BOB) ELISA, can accurately distinguish Zika virus from other viruses, and differentiate it from other flavivirus infections within three hours, according to a recent article in the Proceedings of the National Academy of Sciences. Work to commercially develop the test is just beginning, so the company has not yet submitted it to FDA.

In Vitro Diagnostics United States

Agendia Touts ASCO Guideline's Endorsement Of MammaPrint Breast Cancer Test

Results of the MINDACT trial, which show that Agendia BV's MammaPrint 70-gene lab test can identify about half of the early-stage breast cancer patients who do not need chemotherapy, has led the American Society of Clinical Oncology to specifically recommend the test in its guidelines.

Clinical Trials Market Access

Device Week – July 21, 2017

On this week's Medtech Insight podcast: US Senate passes $2.8bn FDA spending bill; US approvals and clearances strong in first six months of 2017; the global heart-valve repair and replacement devices market is highlighted.

Medical Device FDA

Digital Update: UK Peer Pressure, US Tech Advances And EU Common Goals Put eHealth To Top Of Agenda

Funding is taking a long time to come through for the UK NHS's digital health care transformation, but as the national provider's head of technology strategy, Dr Paul Rice says, "We can't afford to remain non-digital." Estonia, currently holding the presidency of the EU Council of Ministers, gets that too, while US digital champions like Kaiser Permanente and disruptive technology inventors like Mindstrong Health are forcing the pace.

Digital Health Medical Device

First MRI Scanner Designed For NICU Babies Gets US Clearance

Israel's Aspect Imaging has scored the first 510(k) for an MRI machine specifically designed to scan infants in neonatal intensive care units where radiowaves from traditional MRIs could risk interfering with other hospital equipment.

Pediatrics Approvals

OUS Approvals: Neurostim And Cardiovascular Lead June Surge

Approvals of neurostimulation and cardiology devices dominated the list of non-US medtech approvals in June. According to Medtech Insight's Approvals Tracker, there were 36 medtech approvals outside the US last total that month, including 28 CE marks in Europe, plus approvals from China, Canada, Australia/New Zealand and Brazil.

Approvals Innovation